|
Main
|
|
Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
|
Register:
|
ClinicalTrials.gov |
|
Last refreshed on:
|
19 October 2017 |
|
Main ID: |
NCT00661362 |
|
Date of registration:
|
17/04/2008 |
|
Prospective Registration:
|
Yes |
|
Primary sponsor: |
|
|
Public title:
|
Evaluate Efficacy and Safety of Saxagliptin in Combination With Metformin in Adult Patients With Type 2 Diabetes
|
|
Scientific title:
|
A 24-Week International, Multi-centre, Randomized, Parallel-group, Double-blind, Placebo-Controlled, Phase III Study to Evaluate the Efficacy and Safety of Saxagliptin in Combination With Metformin in Adult Patients With Type 2 Diabetes Who Have Inadequate Glycaemic Control on Metformin Therapy |
|
Date of first enrolment:
|
June 2008 |
|
Target sample size:
|
570 |
|
Recruitment status: |
Completed |
|
URL:
|
https://clinicaltrials.gov/show/NCT00661362 |
|
Study type:
|
Interventional |
|
Study design:
|
|
|
Phase:
|
Phase 3
|
|
|
Countries of recruitment
|
|
China
|
India
|
Korea, Republic of
| | | | | |
|
Contacts
|
|
Name:
|
Peter Ohman, MD |
|
Address:
|
|
|
Telephone:
|
|
|
Email:
|
|
|
Affiliation:
|
AstraZeneca |
|
|
Name:
|
Deborah Price, MSc |
|
Address:
|
|
|
Telephone:
|
|
|
Email:
|
|
|
Affiliation:
|
AstraZeneca |
| |
|
Key inclusion & exclusion criteria
|
Inclusion Criteria:
- Diagnosed with Type 2 diabetes
- Treatment with metformin at a stable dose >1500 mg/day
- HbA1c = 7.0% and =10.0%
Exclusion Criteria:
- Insulin therapy within one year of enrolment (with the exception of insulin therapy
during a hospitalization or use in gestational diabetes)
- Type 1 diabetes, history of ketoacidosis, or hyperosmolar non-ketonic koma
Age minimum:
18 Years
Age maximum:
N/A
Gender:
All
|
|
Health Condition(s) or Problem(s) studied
|
|
Type 2 Diabetes
|
|
Intervention(s)
|
|
Drug: Metformin
|
|
Drug: Placebo
|
|
Drug: Saxagliptin
|
|
Primary Outcome(s)
|
|
Absolute Change From Baseline to Week 24 in Glycosylated Haemoglobin A1c (HbA1c)
[Time Frame: Baseline , Week 24]
|
|
Secondary Outcome(s)
|
|
Proportion of Patients Achieving a Therapeutic Glycemic Response
[Time Frame: Baseline , Week 24]
|
|
Absolute Change From Baseline to Week 24 in Fasting Plasma Glucose (FPG) mg/dL
[Time Frame: Baseline , Week 24]
|
|
Absolute Change From Baseline to Week 24 in Fasting Plasma Glucose (FPG) mmol/L
[Time Frame: Baseline , Week 24]
|
|
Change From Baseline in the Area Under the Curve (AUC) From 0 to 180 Minutes for Postprandial Glucose (PPG) During a Mixed Meal Tolerance Test (MMTT) in a Subgroup
[Time Frame: Baseline , Week 24]
|
|
Secondary ID(s)
|
|
D1680C00006
|
|
Source(s) of Monetary Support
|
|
Please refer to primary and secondary sponsors
|
|